Two 3M Veraflo Therapy dressings receive first-ever FDA clearance for hydromechanical removal of non-viable tissue

Rhea-AI Summary

On April 27, 2023, 3M Health Care announced that its 3M™ Veraflo™ Therapy received the first FDA clearance for hydromechanical removal of infectious materials, reducing the need for surgical debridements. This innovative therapy promotes healing by creating an optimal environment for granulation tissue formation.

The FDA clearance is an important milestone, enabling clinicians to provide more effective wound care while potentially reducing healthcare costs. According to 3M, approximately 40% of wounds become infected, which complicates healing and increases costs for health systems. Veraflo Therapy is designed to lower surgical intervention rates and expedite patient recovery.

With the increasing complexity of wound care due to rising patient comorbidities, Veraflo Therapy is positioned as a solution that may improve both patient outcomes and cost efficiency.

Positive

• First FDA clearance for hydromechanical wound therapy, enhancing product credibility.
• Potential to reduce surgical debridements by over 40%, improving patient care efficiency.
• May lead to significant cost savings, estimated at $33,337 per patient.
• Wounds treated with Veraflo are ready for closure almost twice as fast compared to traditional methods.

Negative

• None.

Innovative therapy shown to help promote healing and reduce the need for surgical debridements creating potential savings for health care systems.

ST. PAUL, Minn., April 27, 2023 /PRNewswire/ -- 3M Health Care's innovative 3M™ Veraflo™ Therapy, with both 3M™ Veraflo™ Cleanse Choice Complete™ Dressing and 3M™ V.A.C. Veraflo Cleanse Choice™ Dressing, received the first-ever Food and Drug Administration (FDA) clearance for hydromechanical removal of infectious materials, non-viable tissue and wound debris which reduces the number of surgical debridements required, while promoting granulation tissue formation, creating an environment that promotes wound healing.*

"Veraflo Therapy gives wound care clinicians a proven tool to facilitate healing and reduce the need for surgical intervention," said Dr. Ronald Silverman, 3M Health Care senior vice president of clinical affairs and chief medical officer. "This FDA clearance highlights 3M innovation at its best – using science to help improve patient outcomes with better, smarter, safer health care solutions."

Maintaining a clean wound bed is critical for optimal wound healing. According to 3M Health Care survey of wound care experts, more than 40% of all wounds become infected or critically colonized.¹ This increase in bacterial loads delays and complicates patient wound healing, increasing the resources and costs to care for that patient.  A 2009 study in the Journal of Wound Care found that in the average 500-bed hospital, infected wounds can add an average of 9.58 days to length of a patients stay and $38,656 in additional charges. ² These costs are expected to increase as the population ages and patient comorbidities rise. In 2018, an estimated 8.2 million Medicare beneficiaries had wounds. Wound care costs were estimated to be more than $28 billion, largely driven by delayed healing and complications including the need for surgical debridement.³

"As comorbidities rise, wound healing is getting more complex," said Dr. Paul J. Kim, professor in the Department of Plastic Surgery & Department of Orthopedic Surgery, University of Texas Southwestern. "Solutions that help reduce the number of surgeries and accelerate healing time not only help improve patient recovery, but also lower the total cost of care, creating a more efficient delivery of care for health systems."

3M is proud to have the first and only negative pressure wound therapy (NPWT) dressings that hydromechanically remove non-viable tissue. Veraflo Therapy with Veraflo Cleanse Choice Complete Dressing or V.A.C. Veraflo Cleanse Choice Dressing provides a clinically proven therapy that can reduce the number of required surgical debridements and prepare the wound for closure faster. Data suggests Veraflo Therapy can also help reduce the length of stay and therapy.^4,5 These benefits may create treatment efficiency and cost savings for health systems.⁶

About Veraflo Therapy
Veraflo Therapy is a NPWT with instillation and dwell that helps cleanse and stimulate formation of granulation tissue for patients with open soft tissue wounds. Multiple studies show significant clinical advantages and economic savings versus other advanced wound therapies, including traditional NPWT:

• Wounds ready for closure almost twice as fast (7.88 days vs 14.36 days, p=0.003) ^4,5
• Wounds were 2.39 times more likely to close (p=0.01) ⁴
• Potential savings of 50% or up to $33,337 per patient based on an economic model developed by Dr. Kim comparing the cost of using Veraflo Therapy to traditional wound care options. ⁶
• More than a 40% reduction in the number of required surgical procedures ⁷

For more information on these solutions, including these studies, visit www.3M.com/Veraflo.

NOTE: Specific indications, contraindications, warnings, precautions, and safety information exist for these products and therapies. Please consult a clinician and product Instructions for Use prior to application. Rx only.

About 3M NPWT
3M NPWT has been a global category leader since launching in 1994. 3M NPWT products are trusted in over 60,000 hospitals, homes, and businesses worldwide. More than 10 million wounds have been treated worldwide with 3M™ V.A.C.^® Therapy⁸ and 6 out of 7 clinical studies written about NPWT are based on 3M NPWT systems.⁹ 3M's comprehensive portfolio of advanced wound care solutions is backed by evidence across new and growing categories such as dressings, disposables, digital technology and connectivity. For more information on these solutions, visit www.3M.com/NPWT.

About 3M
3M (NYSE: MMM) believes science helps create a brighter world for everyone. By unlocking the power of people, ideas and science to reimagine what's possible, our global team uniquely addresses the opportunities and challenges of our customers, communities, and planet. Learn how we're working to improve lives and make what's next at 3M.com/news or on Twitter at @3M or @3MNews.

References:
          * K221585

1. September 2014 Survey, N = 240, Surgeons, Podiatrists, WOCNs and PT
2. Posnett J, Gottrup F, Lundgren H, Saal G. The resource impact of wounds on health-care providers in Europe. J Wound Care. 2009;18(4):154-161.1
3. Nussbaum SR, Carter MJ, Fife CE, et al. An economic evaluation of the impact, cost, and medicare policy implications of chronic nonhealing wounds. Value Health 2018;21:27–32. Crossref, Medline, Google Scholar
4. Gabriel A, Camardo M, O'Rorke E, Gold R, Kim P. Effects of Negative-Pressure Wound Therapy With Instillation versus Standard of Care in Multiple Wound Types: Systematic Literature Review and Meta-Analysis, Plastic and Reconstructive Surgery: January 2021 - Volume 147 - Issue 1S-1 - p 68S-76S doi: 10.1097/PRS.0000000000007614.
5. Camardo M. "Veraflo Meta-Analysis Standardized and Non-Standardized Means.", 3M Internal Report, San Antonio, Texas, 2020.
6. Kim PJ, Lookess S, Bongards C, Griffin LP, Gabriel A. Economic model to estimate cost of negative pressure wound therapy with instillation vs control therapies for hospitalized patients in the United States, Germany, and United Kingdom. Int Wound J. 2021;1–7
7. Milcheski D, Clivatti G, González C, et al. Effectiveness of Traumatic Wounds Treatment with Negative-pressure Wound Therapy with Instillation: Pragmatic Randomized Control Trial: 2021. Hospital das Clinicas, Sao Paulo, Brazil.
8. 3M. Cumulative NPWT Wounds. 2018.
9. 3M. Cumulative NPWT Wounds. 2021.

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SOURCE 3M

FAQ

What new product did 3M receive FDA clearance for on April 27, 2023?

3M received FDA clearance for its 3M™ Veraflo™ Therapy.

How does Veraflo Therapy impact surgical procedures?

Veraflo Therapy may reduce the need for surgical debridements by over 40%.

What are the estimated cost savings of using Veraflo Therapy?

Using Veraflo Therapy could save up to $33,337 per patient.

How quickly can wounds close using Veraflo Therapy compared to traditional methods?

Wounds can be ready for closure almost twice as fast, taking approximately 7.88 days.